Fungal Infection in Patients in Intensive Care Units

Fungal Infection Clinical Trial

Official title:

Predictors of Fungal Infection in Non-neutropenic Patients in Intensive Care Units

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04684342
• Other study ID #: Fungal infection in ICU
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2021
• Est. completion date: March 2022

Study information

• Verified date: December 2020
• Source: Assiut University
• Contact: Mahmoud A. Abdelmoula
• Phone: 01113983636
• Email: abdou.mahmoud93[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Predictors of fungal infection in non-neutropenic patients in intensive care units and the aim of the study is To evaluate the frequency of fungal infection in non-neutropenic patients in Intensive Care Units.

To evaluate the risk factors of fungal infection in these patients.

Description:

The incidence of candidemia in the overall population ranges from 1.7 to 10 episodes per 100,000 inhabitants and Candida is one of the ten leading causes of bloodstream infections in developed countries. An estimated 33-55% of all episodes of candidemia occur in intensive care units (ICU) and are associated with mortality rates ranging from 5% to 71%. Candida fungemia may have an endogenous or an exogenous origin, and in recent years a growing proportion of episodes of candidemia have been caused by Candida species other than albicans. The most important independent conditions predisposing to candidemia in ICU patients include prior abdominal surgery, intravascular catheters, acute renal failure, parenteral nutrition, broad-spectrum antibiotics, a prolonged ICU stay, the use of corticosteroids and mucosal colonization with Candida. In recent years, several studies have shown that ICU patients with mucosal Candida colonization, particularly if multifocal, are at a higher risk for invasive candidiasis, and that colonization selects a population amenable to antifungal prophylaxis or empirical therapy. Candidemia in ICUs is associated with a con- siderable increase in hospital costs and length of hospital stay.

Invasive fungal infection (IFI) is a grave infection associated with serious effects in patients with chronic diseases including liver cirrhosis. The diagnosis of IFI re- quires histopathological evidence of tissue invasion, or isolation in blood cultures, or isolation from a normally sterile body fluid or site, with samples collected intra-op- eratively or by percutaneous needle aspiration. Awareness of IFI has been increased in clinical practice with the increased survival of patients in immunocompromised states. Such infections are associated with a high morbidity and significant mortality, requiring early diagnosis and appropriate treatment, but also optimal prophylaxis in patients at high risk.

Globally, several studies had assessed fungal infections in non-neutropenic patients, however, to our knowledge, searching for fungal infections in these patients are un- derestimated in our locality.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: March 2022
• Est. primary completion date: January 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Adult Patients with liver cirrhosis that will be clinically suspected to have in- fection.

Exclusion Criteria:

• Age < 18 years

Related Conditions & MeSH terms

• Communicable Diseases
• Fungal Infection
• Infection
• Mycoses

Intervention

Diagnostic Test:
• Routine Laboratory investigations
Complete blood picture Liver function test and prothrombine time & concentration. Blood urea and creatinine Blood glucose, serum Na and K CRP and ESR Clinical specimens will be collected from patients according to the suspected site of infection (e.g. blood, urine, ascitic fluid, sputum or endo- tracheal aspirates) VITEK 2Compact inflammatory markers

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (3)

Bucsics T, Schwabl P, Mandorfer M, Peck-Radosavljevic M. Prognosis of cirrhotic patients with fungiascites and spontaneous fungal peritonitis (SFP). J Hepatol. 2016 Jun;64(6):1452-4. doi: 10.1016/j.jhep.2016.01.039. Epub 2016 Feb 23. — View Citation

Leon DA, McCambridge J. Liver cirrhosis mortality rates in Britain from 1950 to 2002: an analysis of routine data. Lancet. 2006 Jan 7;367(9504):52-6. Erratum in: Lancet. 2006 Feb 25;367(9511):650. — View Citation

Runyon BA; AASLD. Introduction to the revised American Association for the Study of Liver Diseases Practice Guideline management of adult patients with ascites due to cirrhosis 2012. Hepatology. 2013 Apr;57(4):1651-3. doi: 10.1002/hep.26359. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	frequency of fungal infection in cirrhotic patients	frequency of fungal infection in cirrhotic patients	4 months